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Recurrence Rate and Esthetic Outcome After Excision of Basal Cell Carcinomas Excluded From Trial NCT00515970

This study is enrolling participants by invitation only.
Sponsor:
Information provided by:
University Hospital Tuebingen
ClinicalTrials.gov Identifier:
NCT00639652
First received: March 14, 2008
Last updated: NA
Last verified: March 2008
History: No changes posted

March 14, 2008
March 14, 2008
December 2007
December 2013   (final data collection date for primary outcome measure)
Recurrence of basal cell carcinoma (BCC) [ Time Frame: Within 4 years after surgery ] [ Designated as safety issue: Yes ]
Same as current
No Changes Posted
  • Subjective assessment of the esthetic outcome of the scar on a scale of excellent, good, satisfying, moderate, unfavorable; done by a private practitioner. [ Time Frame: 12 and 48 months after surgery ] [ Designated as safety issue: No ]
  • Subjective assessment of the esthetic outcome of the scar on a scale of excellent, good, satisfying, moderate, unfavorable; done by the patient. [ Time Frame: 12 and 48 months after surgery ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Recurrence Rate and Esthetic Outcome After Excision of Basal Cell Carcinomas Excluded From Trial NCT00515970
Observational Study: Recurrence Rate and Esthetic Outcome After Excision of Basal Cell Carcinomas Excluded From Trial NCT00515970

Currently, we conduct a prospective, randomized trial comparing the outcome of surgical excision with the outcome of curettage in nodular and superficial BCCs. Larger BCCs and micronodular or sclerosing BCCs are not included in the randomized study. They are mainly operated using three-dimensional histology (3D-histology, micrographic surgery). In this observational study we measure the cosmetic result and the recurrence rate of all BCCs not included in the randomized trial.

  1. Disinfection
  2. Local anesthesia
  3. Surgery
  4. Dressing
  5. Preparation with paraffin for histopathologic evaluation
  6. Staining with hematoxylin-eosin
  7. Adjuvant radiotherapy is not applied in any of our patients.
  8. If histopathology discovers another tumor than BCC, the tumor is excluded.
  9. If recurrence is suspected, a punch biopsy is taken. If recurrence is confirmed, the endpoint is achieved.
  10. Patients who provide no feedback receive phone calls.
  11. The patient receives a letter containing a list of the BCCs treated within the study. She or he is asked to visit the private practitioner with the list after 12 and 48 months (+/- 30 days) referring to the last operation in the recruitment period. The practitioner or the patient return the questionnaire to our department.
  12. The letter contains a questionnaire about suspicion of recurrence of BCC.
  13. The patient is asked to assess the esthetic outcome on a scale of excellent, good, satisfactory, mediocre, and poor.
  14. The physician is asked to assess the esthetic outcome on a scale of excellent, good, satisfactory, mediocre, and poor.
  15. When follow-up is closed for an individual patient, the reason is recorded:

    1. Planned end of follow-up after 48 months
    2. Patient has moved.
    3. Death (date of death)
    4. Consent withdrawn
    5. Meanwhile, the patient has become so ill or high-maintenance that no more follow-up visits can be planned.
    6. Recurrence of all of the patient's BCCs with histopathologic confirmation.
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Retention:   Samples Without DNA
Description:

Paraffinized histology blocks and sections.

Probability Sample

BCCs excluded from the randomized trial NCT00515970

Carcinoma, Basal Cell
  • Procedure: 3D-histology
    The tumor is marked at the 12 o'clock-position. Excision with a safety margin between 2 and 10 mm, depending on tumor size and location. Plastic reconstruction. Removal of the specimen's margins and base as thin layers, using a scalpel. These primarily three-dimensional layers of the specimen's borders are flattened to one level and microscopically screened for tumor cells. 3D-histology is combined with representative vertical sections for histologic diagnosis. Consecutive excisions are performed topographically at the tumor-positive areas and 3D-histology is repeated until tumor-free margins are obtained.
    Other Names:
    • Micrographic surgery
    • Histographic surgery
    • Mohs surgery
  • Procedure: Shave excision
    Tumor removal by shave excision with a safety margin. Healing by secondary intention. Histologic diagnosis of BCC type (nodular, superficial, morpheaform, micronodular, other type, mixed type) or diagnosis of another tumor than BCC. Comment on complete removal (R0 versus R1).
  • 1. 3D-histology
    Nodular, micronodular, or sclerosing BCCs
    Intervention: Procedure: 3D-histology
  • 2. Shave excision
    Superficial BCCs
    Intervention: Procedure: Shave excision
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Enrolling by invitation
800
December 2013
December 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • BCCs excluded from the randomized trial NCT00515970

Exclusion Criteria:

  • Treatment other than with 3D-histology or shave excision (e.g. deep surgical excision without 3D-histology)
Both
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT00639652
16/2008BO2
No
Helmut Breuninger, Department of Dermatology, Eberhard Karls University
University Hospital Tuebingen
Not Provided
Study Chair: Helmut Breuninger, M.D. Eberhard Karls University Tuebingen, Department of Dermatology
Principal Investigator: Kay Brantsch, M.D. Eberhard Karls University Tuebingen, Department of Dermatology
University Hospital Tuebingen
March 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP